Method to provide injection system parameters for injecting fluid into patient

ABSTRACT

Automated injection system disclosed in this application advantageously provides physicians with a simplified interface for selecting fluid sources, such as saline, contrast, or a mixture of both, to inject at high pressures. The injector system may comprise a multi-use subassembly, a single-use subassembly, a fitting to fluidly connect the multi-use and single-use subassemblies, a hand held controller, a user interface, and an injector housing.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. 119(e) to U.S.provisional patent application 61/754,687, filed Jan. 21, 2013, andclaims priority under 35 U.S.C. 120 as a continuation-in-part ofPCT/US13/61397 filed Sep. 24, 2013, of which are incorporated herein byreference.

FIELD OF THE INVENTION

The disclosure generally relates to fluid dispensing machines and, moreparticularly, relates to fluid injection systems and methods used toautomatically inject various fluids, such as saline, contrast, or amixture of both, into a patient.

BACKGROUND

During medical procedures fluids of different types need to be injectedinto human tissue and vascular structures. Various medical proceduresrequire a radiographic image of a vascular structure to be obtained byinjecting radiographic contrast material through a procedure catheterinto a hollow anatomical structure, such as a blood vessel, artery,vein, or heart chamber. X-rays are then passed through the region of thebody in which the contrast material was injected. The X-rays areabsorbed by the contrast material causing a radiographic outline orimage of the hollow anatomical structure containing the contrastmaterial. The x-ray images of the hollow anatomical structures filledwith the contrast material are usually recorded on memory, such as onfilm or videotape, and displayed on a fluoroscope monitor. When a seriesof different fluids are to be administered, or a series of injectionsare required, it is often necessary to flush one fluid from theinjection line before the next fluid is administered. For example,during angioplasty, the procedure catheter is often flushed with salinebefore and/or after the addition of contrast solution. Further, it isalso necessary to purge any injection lines of air and to prevent thereintroduction of air into the lines.

The injection of the contrast or other fluids can be performed eithermanually or automatically. In both injection procedures, a procedurecatheter is inserted into a hollow anatomical structure, which in turnis connected to a fluid line leading to a valve or manifold which is influid communication with an injector or syringe. The plunger of theinjector or syringe is then either manually or automatically depressedto inject fluid through the fluid line, through the procedure catheter,and into the patient.

The most commonly used apparatus for these types of procedures involvesthe connection of a catheter to a valve or manifold having a number ofstopcock valves. Movement of fluids between selected fluid sources,other apparatus, and to the procedure catheter and patient is typicallyaccomplished with a syringe or other manual injection device. Thephysician is typically required to selectively open and close the valvesor manifold to control the source, path and direction of the fluid flowduring a procedure. The physician may also be required to draw fluid,take a blood sample, remove waste, inject medication, or flush fluid outof the injection device repeatedly during a procedure.

Because a physician is required to manipulate a number of stopcockvalves during a procedure to achieve a desired flow path to or from theprocedure catheter, it takes training to learn how to properly operateone of the prior art manifolds. Further, because it may not beimmediately evident from looking at the manifold which way the fluid isflowing, it is easy to make an improper connection resulting in nounintended fluid delivery into the patient. Because a number of stopcockvalves are involved in the prior art manifolds, the handles must besmall so as to not cause interference with one another. However, thesmall handles can be difficult to grasp and manipulate. Additionally,physicians often develop a “tactile feel” for infusing fluids throughcatheters with the syringe or other injection device, maintaining theinfusion pressure within desired pressure ranges to avoid damagingcatheters, vessel dissection, damaging catheter balloons orunintentional damage to any hollow anatomical structures while stillachieving flows sufficient for contrast-enhanced imaging.

In certain situations, it is necessary to dilute the concentration ofcontrast being injected into a patient. For example, in those patientswith renal insufficiency incapable of processing concentrated contrastthrough their system, or in cases where a large amount of contrast isused, such as complicated coronary interventions (PTCA) or peripheral(PTA) cases with runoffs, direct injections of contrasts, are notdesired. Accordingly, it may be necessary to mix the contrasts andsaline prior to injection to arrive at the appropriate dilutionpercentage. The goal is to obtain a dilution percentage that is safe forthe patient and still provides a clear image. Such processes arenecessarily slow and are currently difficult to achieve using knowninjectors in the art. There is a need in the art to easily mix contrastand saline in-line and control the dilatation of the concentration ofcontrast being injection; thereby preventing unnecessary contrast fromentering the patient's body and also reducing overall contrast usedallowing for a cost saving by the hospital.

To address these issues, an improved automated fluid management systemhas been developed and is disclosed herein. Automated injection systemdisclosed in this application advantageously provide physicians with asimplified process for selecting fluid sources to inject into hollowanatomical structures at high pressures up to 1400, and typicallybetween 900-1200 psi.

Traditional injection procedures for coronary injections as commonlyknown in the art may include the use of a manifold, as described above,for controlled injections of both saline and contrast. If high volumeinjections are then required the manifold may be removed and the usermay have to then attached an automated injectors to the procedurecatheter. Therefore, a need in the art exists, of which this inventionsatisfies, for an automated injector that can be used with controlledinjection of both saline and contrast. An advantage of this system isincorporating the ability to perform controlled injections historicallydone by manifolds together the ability to simultaneously automateinjection of contrast, saline, or a mixture of both in-lines at highpressures.

SUMMARY OF THE INVENTION

In accordance with one aspect of the disclosure, an injection system isprovided which may comprise of a multi-use subassembly, a single-usesubassembly, a fitting to fluidly connect the multi-use and single-usesubassemblies, a hand held controller, a user interface, and aninjector. The multi-use subassembly may comprise a protective shell, atleast one power actuated syringe, and at least one automated rotaryvalve, a venting system, and high pressure tubing. The single-usesubassembly may comprise high pressure tubing, pressure protectionvalve, pressure transducer, and a catheter connection. In thisembodiment, the multi-patient subassembly may be capable of multipleinjections for a single patient, multiple patients, whereas thesingle-use subassembly may be capable of multiple injections for asingle patient.

In accordance with another aspect of the disclosure, an injection systemmay also comprise a portable cart and a mounting system. The mountingsystem comprises different mounting subassemblies, including but notlimited to, a cart mounting option, a rail or bed mounting option, and aceiling or wall mounting option.

In yet another embodiment of the invention, the injection system maycomprise a multi-use subassembly, a single-use subassembly, a hand heldcontroller, a user interface, an injector housing, and a fitting tofluidly connect the multi-use and single-use subassemblies for singlepatient use only. In this embodiment, the multi-use subassembly andsingle-use subassembly may both be capable of multiple injections butfor only a single patient use. The purpose of this embodiment is so theinjection system may be used in combination with a contrast sourceintended for single patient use only.

Key advantages of this invention include an improved monitor/userinterface system to facilitate automated and preset and/or customizableinjections; ability to simultaneously inject a mixture of fluids (suchas a mixture of saline and contrast) in line and in real time;interchangeable multi-use disposables to facilitate setup andpreparation of injection system; an automated purge system; a specialrotary valve for automated fill and injection; convex faced syringebarrel; enhanced rear barrel support means, hand controller providinguser with a tactile or haptic feel during injections, and a side exitport syringe barrel used to shorten the shell and decrease overallinjector footprint.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic drawing of one embodiment of the injection system.

FIG. 2 is a side perspective view of the injection system.

FIG. 3a is a side perspective view of the injector with cover closed; 3b is a side perspective view of the injector with the cover open.

FIG. 4 is a side perspective view of the injector after the multi-usesubassembly has been placed.

FIG. 5 is a side perspective view of the syringe barrel.

FIG. 6 is a rear perspective view of the outer protective shell.

FIG. 7 is a side top perspective view of the outer protective shell.

FIG. 8 is a top cross-section view of the multi-use subassembly.

FIG. 9 is a side perspective view of the multi-use subassembly.

FIG. 10 is a rear perspective view of the multi-use subassembly.

FIG. 11 is an exploded perspective view of the multi-use subassembly.

FIG. 12 is a partial top cross-sectional view of the multi-usesubassembly.

FIG. 13 is a partial top cross-sectional view of the automated valve inthe inject position.

FIG. 14 is a partial top cross-sectional view of the automated valve infill or purge position.

FIG. 15 is a partial top cross-sectional view of the automated valve ina closed position.

FIG. 16 is an exploded view of the multi-use subassembly highlightingthe venting system.

FIG. 17 is a cross-sectional view of the multi-use subassemblyhighlighting the venting system.

FIG. 18 is a partial perspective cross-sectional view of the ventingsystem.

FIG. 19 are partial side cross-sectional views of syringe barrel andplunger position during venting.

FIG. 20 is a side perspective view of the injector housing, specificallythe syringe support means.

FIG. 21 is a top perspective view of the injector housing, specificallythe syringe support means.

FIG. 22 is a side perspective view of the injector housing, specificallythe syringe support means and the multi-use subassembly.

FIG. 23A is a side perspective view of the injector housing,specifically the syringe support means and the multi-use subassembly.

FIG. 23B is a side perspective view of the injector housing,specifically the syringe support means and the multi-use subassemblywith lift support.

FIG. 24a is a side perspective view of the quick connect fitting; FIG.24b is a top perspective view of the quick connect fitting; FIG. 24c isan additional side perspective view of the quick connect fitting.

FIG. 25 is a side perspective view of the fitting housing in an openposition.

FIG. 26 is a side perspective view of the fitting housing in a closedposition.

FIG. 27 is a side perspective view of the fitting housing in a lockedposition.

FIG. 28 is a side view of the single-use subassembly.

FIG. 29 is an exploded perspective view of the single-use subassembly.

FIG. 30 is an exploded perspective view of the pressure protectionvalve.

FIG. 31 is a side cross-sectional view of the pressure protection valve.

FIG. 32 is a side perspective view of the hand controller.

FIG. 33 is a rear perspective view of the hand controller.

FIG. 34 is an exploded perspective view of the hand controller.

FIG. 35 is a side perspective view of the mounting system.

FIG. 36 is a side perspective view of the mounting system securelyattached to a bed.

FIG. 37 is a partial side perspective view of the mounting system.

FIG. 38 is a partial side perspective view of the mounting system beingattached to the injector housing.

FIG. 39 is a partial side perspective view of the mounting system beingattached to the injector housing.

FIG. 40 is a partial side perspective view of the mounting systemsecurely attached the injector housing.

FIG. 41A is a schematic of the interface system of the system of FIG. 2.

FIG. 41B is an illustration of a Start Screen of the display of thesystem of FIG. 2.

FIG. 42 is an illustration of a Setup Screen of the display of thesystem of FIG. 2.

FIG. 43 is a diagrammatic flow chart illustrating the process used toattach the multiple-use subassembly to the injection housing of thesystem of FIG. 2.

FIG. 44 is a diagrammatic flow chart illustrating the process used tofill and vent the syringes of the multiple-use subassembly of the systemof FIG. 2.

FIG. 45 is a diagrammatic flow chart illustrating the process used tofill and prime the tubing and transducer of the single-use subassemblyof the system of FIG. 2.

FIG. 46 is a diagrammatic flow chart illustrating the process used toselect the procedure type for the system of FIG. 2.

FIG. 47 is a diagrammatic flow chart illustrating the process toautomatically fill the syringes of the multiple-use subassembly of thesystem of FIG. 2.

FIG. 48 is an illustration of a Dashboard Screen of the display of thesystem of FIG. 2.

FIG. 49 is an illustration of an Armed Dashboard Screen of the displayof the system of FIG. 2.

FIG. 50 is an illustration of a Shell Option Screen of the display ofthe system of FIG. 2.

FIG. 51 is an illustration of a Source Options Screen of the display ofthe system of FIG. 2.

FIG. 52 is an illustration of a Patient Options Screen of the display ofthe system of FIG. 2.

FIG. 53 is an illustration of a Summary Screen of the display of thesystem of FIG. 2.

FIG. 54 is a diagrammatic flow chart illustrating the process to removethe multiple-use subassembly of the system of FIG. 2.

FIG. 55 is an illustration of a Settings Screen of the display of thesystem of FIG. 2.

FIG. 56 is an illustration of a Help Screen of the display of the systemof FIG. 2.

DETAILED EMBODIMENTS

As seen in FIG. 1, a schematic of the automated fluid injection system 1is shown. The injector system 1 is comprised of various components orsubassemblies that may be combined together to form the overall system1. The injector system 1 may allow the user to monitor invasivepressures or vascular blood pressure monitoring and perform dualinjections of contrast, saline, a mixture of contrast and saline, or anyother fluid, with the ability for variable mixing during medicalprocedures. The injection system 1 is capable of injecting fluids fromthe barrel 35 at both low and high pressures, for example any pressureup to 1,400 PSI or the pressure required by maximum catheterspecifications as currently known in the art. The injector system 1 mayinclude, but is not limited to, the user interface 7, a hand controller9, at least one injector ram 15, at least one fluid source 23, amulti-use subassembly 3, a fitting housing 4, and a single-usesubassembly 5. The hand controller 9 may further comprise, but is notlimited to, a selector 303, an actuator 301, a sensor 313, and afeedback means 311. The multi-use subassembly 3 may further comprise,but is not limited to, at least one syringe barrel 35, an air purge orventing system 43, at least one automated valve 45. The fitting housing4 may further comprise, but is not limited to, a fitting 133 and an airsensor 155. The single-use subassembly 5 may further comprise, but isnot limited to, a dual lumen high pressure line 209, a tubing junction211, a pressure protection valve 207, a disposable pressure transducer203, a single lumen high pressure line 213, a stopcock 215 and acatheter connection 219. The single-use subassembly 5 may be in fluidconnection with a procedure catheter (not shown). As described in moredetail below, the various components and subassemblies shown in theschematic of FIG. 1 may change depending on the needs of the user.

FIGS. 2-4 depicts one embodiment of the injector system 1. The injectorsystem 1 may comprise of various components or subassemblies including,but not limited to, a multi-use subassembly 3, a single-use subassembly5, a user interface 7, a hand controller 9, an injector housing 13,fluid source 23, a foot pedal 10, cover 6, locking handles 31, and acart 19. For the sole purpose of clarity the cover 6 has been removedfrom FIGS. 2 and 4. The injector system 1 may also comprise a mountfinger 14, a mounting plate 407, a connection arm 17, and a motorizedbase 409. The connection arm 17 is used to securely attach the injectorhousing 13 to a mount plate 407. A key feature of the injector system 1is the interchangeable mounting system, described in more detail below,that allows the injector to be secured to various securement structuresincluding, but not limited to, a cart 19, a bed rail 411 (as seen FIGS.35-40), or a ceiling or wall mount (not shown).

The fluid sources 23 containing either saline or contrast may be securedto the housing 13 with a source arm 25. The arm 25 may be hinged orpivotally connected to the housing 13. The arm 25 may be collapsible orfoldable to allow the user to reduce the footprint of the injectorhousing 13 when not in use. The user interface 7 may be securelyattached to the housing 13 by an interface arm 11 that pivotally extendsor retracts. It is advantageous that the user interface 7 is able toswing, pivot, or otherwise be manipulated in multiple directions duringa procedure. It is common for the injector housing 13 to be placed awayfrom the user during a procedure due to limited space, for example onthe opposite side of the bed, so having the ability to manipulate theinterface 7 in various directions is an advantage over injectorscurrently known in the art. The interface may have an identificationcard swipe 8. The hand controller 9 may be connected to the userinterface 7 using various techniques, as described below, including acontrol cable 305. Similarly, the foot pedal 10 may be connected to userinterface 7 using various techniques including a control cable 18.

The interface 7 is intended to control and display various aspects ofoperating the injector including, but not limited to, setting injectionparameters, automated purging of system, automated injection, displayingreal time injection status, and providing a user friendly interface forinjector. Various selection tabs on the interface 7 may becomehighlighted, flash, grayed out, or have a visual indicator in order todepict and verify to the user that tab has been selected. An advantageof user interface 7 is that it reduces the user learning curve byprogramming the interface 7 to make it easier for users to navigate thesystem and simplify or automate the purging and injection sequences soto reduce possible user error. The interface 7 may be interactive via atouch screen so that user can select an option simply by pressing avisual aid on the screen. Alternatively, interface 7 may be voiceactivated or controlled via voice commands so instead of physicallypressing a screen or tablet computer a user may control interface 7using a head set or other similar voice command device.

The interface 7 may be software based and incorporated onto a touchscreen tablet, PC, or a digital application used on a smart phone.Additionally, interface 7 may provide a shorter or faster setup timeallowing for more time to conduct procedures. Interface 7 may providefor automatic syringe refill and air purging. The automatic refilloption minimizes waste by allowing user to input a required amount ofcontrast, saline, or other fluid to be used per case. User may also beable to define a maximum limit for total contrast or saline that can beinjected into the patient with integrated warning signals to notify userwhen maximum has been reached.

The interface 7 may have a card swipe 8 or identification card reader asknown in the art, as seen in FIG. 2. The purpose of the card swipe 8 isto allow the user to simply swipe their hospital identification card andthe interface will automatically bring up preset settings. Thesesettings may be changed at any time but having the ability toautomatically call up preset settings may save the user time.

As seen in FIG. 3a -FIG. 4, housing 13 has a loading area 12 that themulti-use subassembly 3 may be placed or inserted into during setup.FIG. 3a shows the loading area 12 without the multi-use subassembly 3 inplace. The loading area 12 has at least one valve actuator 16. The valveactuator 16 is designed so that the tab 46 of the automated valve 45(see FIG. 4) may fit securely within the valve actuator 16. The movementof the valve actuator 16 is controlled by the interface 7 or handcontroller 9. As described in more detail below, when the valve actuator16 moves or rotates it simultaneously moves or rotates the valve tab 46thereby controlling the position automated valve 45. The loading area 12also may comprise a fitting housing 4 used to securely enclose thefitting that connects the multi-use assembly 3 to the single-useassembly 5. The loading area 12 may also comprise visual identifiers(not shown). The visual identifiers may include at least one light orLED (not shown) used to provide visual identification to the user of thecurrent status of the injector. For example, the loading area 12 mayhave two visual identifiers in the form of different colored LEDs (notshown), one color to represent contrast and one color to representsaline. Each LED may be placed adjacent to the automated valve 16. EachLED may light up and provide user notice during injection of fluid orfiling, purging, or venting of a barrel. For example, if just saline isbeing injected then only the corresponding LED is activated; if justcontrast is being injected then only the corresponding LED may beactivated; if both contrast and saline is being injected both LEDs maybe activated.

Multi-use subassembly 3 may be inserted into loading area 12 and securedto the injector via a locking means such as a cover 6. To load themulti-use subassembly 3 into the loading area 12 the user must unlockthe cover 6 by rotating the locking handles 31 and lifting the cover 6away from the loading area 12, as seen in FIG. 3b . Once the cover 6 hasbeen lifted, the user may place the multi-use subassembly 3 on theloading area 12 of the injector housing 13. The multi-use subassembly 3is secured to the loading area 12 and injector housing 13 by placing thesecurement ridge 59 of barrels 35 into the rear barrel support means 79,as described in more detail below. Once the multi-use subassembly 3 isin place on the loading area 12 the user may close the cover 6 androtate the locking handles 31 to securely enclose the multi-usesubassembly 3 to the injector housing, as seen in FIG. 4.

The multi-use subassembly 3 may comprise of at least one syringe barrel35 as seen in FIG. 5. Barrel 35 may further comprise a front end 51,back end 53, a first port 55, a second port 57, a securement ridge 59,an alignment nub 63, and anti-rotation means. The front end section 51of syringe barrel 35, and similarly the front end section 64 ofprotective shell 61 as seen in FIG. 6-7, may be a semi-spherical convex,rounded, or bullet shape. An advantage of front end sections 51 having asemi-spherical or convex front profile is a reduction in stress pointsor risers. Stress risers occur at corners and/or sharp angles oninjection-molded devices. By eliminating the sharp corners present in aconical shaped barrel, the component will be less prone to premature,stress-induced failures under high pressure conditions generated bypower injection. An advantage of this design is an increase in strengththat allows barrel 35 to be used multiple times under high pressureconditions. The front face 51 of barrel 35 also shortens overall barrellength—relative to standard conical shaped syringe barrels known in theart—allowing for smaller multi-use subassembly 3 and small injectorfootprint. It is advantageous for the injector to have a reducedfootprint and overall smaller size because the procedure room in whichinjector is user becomes very crowded and space becomes limited. Thedesign of this embodiment helps reduce overall size of injector therebyproviding more room around the injector for hospital personnel to freelymove. Syringe barrel 35 may be made from various materials able towithstand high temperatures or pressures including, but not limited to,clear polycarbonate, clear abs, or ultem.

The securement ridge 59 may be located towards the back end 53 of thebarrel and extend radially a selected distance around the barrel 35. Thesecurement ridge 59 may be injection molded together with barrel 35 tocreate a single piece component. Securement ridge 59 is shaped to fitwithin the rear barrel support means, as described in more detail below.The purpose of the securement ridge 59 is to provide additional supportto the barrel 35 and also a means for securely connecting or attachingthe barrel 35 to the injector housing 13. During injections the barrel35 may come under high forces so it is important that the securementridge 59 can withstand such forces because the ridge 59 may be theconnection point for securely attaching barrel 35 to injector.

The first port 55 is used to fill and inject fluids from the syringebarrel 35. The first port 55 can be located along the front end 51 ofsyringe barrel 35 and provides a fluid communication channel between theautomated valve and interior of barrel body. In one embodiment, as shownin FIGS. 5 and 8, the first port 55 is positioned towards the front end51 and bottom wall 54 and below the center axis of barrel 35.

First port 55 may be positioned on the front face 51 near the transitionzone 65 between the barrel body and the front face 51. An advantage ofpositioning the first port 55 along the side wall of syringe barrel 35is shortening the overall barrel length, thereby allowing for a smallermulti-use subassembly 3. Additionally, when the first port 55 ispositioned along the side wall of barrel 35 the port 55 may be located aselected distance proximal to the tapering zone 65, an area along frontend 51 of syringe where barrel 35 transitions from straight side wall toshaped end face, thereby reducing the risk of barrel cracking orfatigue. First port 55 of syringe barrel 35 may be inverted into thebarrel 35, as seen in FIG. 12. An advantage of this design allows barrel35 to be front loaded into the shell 61, as will be described in detaillater.

The second port 57 located on top surface of securement ridge 59 is usedfor purging or venting the barrel 35 of unwanted air, as described inmore detail below. The second port 57 may be located along the top ofthe securement ridge 59 as seen in FIG. 5. The second port 57 mayprovide fluid communication between inside the barrel chamber and aone-way check valve 113 a, 113 b of the venting system, as described inmore detail below. Alternatively, the second port 57 may be located onthe top wall 56 of the barrel 35 towards the back end 53 of the syringebarrel 35.

Referring now to FIG. 6-7, the system may include an outer protectiveshell 61 as a means of additional support intended to prevent syringebarrel 35 from over expansion, cracking, leaking or bursting during use.The protective shell 61 may include, but not limited to, a convex shapedfront end 64, port holes 58, anti-rotation grooves 52 along the innerwall 60, alignment holes 62, placement tabs 68, connection arms 70, andthe bottom half 92 of the fill chamber. Shell 61 may comprise twoseparate enclosure containers 66. The shell 61 is designed so eachbarrel 35 may be independently placed inside an enclosure container 66.Each container 66 has a port hole 58 that aligns with the first port 55of the barrel 35. At least one connection arm 70 extending off eachcontainer 66 may securely attach to the bottom half 92 of the fillchamber, thereby connecting both containers 66 to form a single shell61. The fill chamber 92 is part of the venting system 43 and isdescribed in more detail below. Each container 66 may have a placementtab 68 so user may grip or hold the shell 61 during insertion or removalfrom injection housing 13. Shell 61 may be made from various materialsable to withstand high temperatures or pressures including, but notlimited to, clear polycarbonate or ultem.

The multi-use subassembly 3 may contain anti-rotation means to preventthe barrel 35 from twisting or rotating out of alignment during aninjection or manufacture/assembly of the multi-use subassembly 3. Asseen in FIG. 5-7, the barrel 35 and shell 61 are separate components andthe anti-rotation means is used to ensure that the barrel 35 remainsaligned within the shell 61 during use. The anti-rotation means on thebarrel 35 may include an alignment nub 63 along the front end 51 andraised notches 50 along the outer surface of the barrel 35. Theanti-rotation means of the shell 61 may include an alignment hole 62along the front end 64 and groove 52 on inner wall 60, as seen in FIG.6-7. The alignment nub 63 is designed to align with and abut or bereceived into a corresponding alignment hole 62 of the shell 61.Similarly, the raised notch 50 along barrel 35 outer surface aligns andfits within grooves 52 of shells 61 inner wall 60, thus properlyaligning the outer surface of barrel 35 and inner wall 60 of shell 61.While it is important to prevent the barrel 35 from become out ofalignment, an expansion gap may exist between the outer diameter of thebarrel 35 and inner wall 60 of the shell 61 to permit certain expansionthat may occur during use. For example, as seen in FIG. 8 an expansiongap 72 may exist towards front end of barrel. The purpose for anexpansion gap 72 is to allow the barrel 35 to expand or stretch apredetermined amount during injections but prevent the barrel 35 fromoverexpansion or overstretching to the point of failure. Therefore thesize of expansion gap 72 may vary depending on how much room the syringebarrel 35 needs to expand or stretch but yet still be reinforced byshell 61 to prevent failure.

Referring to FIGS. 9-11, one embodiment of the entire multi-usesubassembly 3 with all of its components is shown. The multi-usesubassembly 3 of this embodiment may comprise two syringe barrels 35securely enclosed within an outer protective shell 61, a venting system43, automated valves 45, and tubing lines 47, 41. The ridges 59 are notenclosed by the shell 61 because the ridges 59 may attach to the rearsecurement means 79, as described in more detail below. The automatedvalves 45 fluidly connect the barrels 35 to the fill tubing 41 orconnection tube 107 and injection tubing 47. The fill tubing 41,connection tube 107 and injection tubing 47 may incorporate flexible,large inner diameter high pressure tubing to enable user to visualizeany trapped air in tubing sets and achieve desired high pressure flowrates while maintaining flexibility. The fill tube 41 may contain bagspikes 40 as known in the art to fluidly connect the fill tubes 41 withthe fluid sources. Injection tubing 47 may be fluidly connect thebarrels 35 to the fitting 133. Dedicated fluid lines may minimize fluidwaste and injection fluid lag. The tubing lines 41, 47 may be eitherclear or have a specific color to represent the type of fluid present.For example, the tube carrying saline may have a blue line or tint alongits length so the user may easily visualize the tubing linecorresponding to the delivery of saline.

As seen in FIG. 11, plunger 36 may comprise of a plunger body 37, cover39 and securement nub 34. As described in more detail below, thesecurement nub 34 along the rear wall of body 37 may be used whensecuring the multi-use subassembly 3 to the injector housing 13. Plungercover 39 may be sized so it can freely slide along inner wall of barrel35 while all sides of cover 39 converge on or abut against the innerwall of barrel 35.

As seen in FIG. 12-15, the multi-use subassembly 3 may include speciallydesigned automated valves 45. Automated valve 45 may be a Y-shapedrotary valve. The automated valves 45 may include a valve stem 42, valvetab 46, and may be comprised of three different channel elements: a fillchannel 44, an injection channel 38, and a barrel channel 48. Valve stem42 is inserted and securely attached to first port 55 of the barrel 35.Stem 42 may be secured by adhesive or other known methods in the art.The barrel channel 48 connects to first port 55 of barrel 35 via valvestem 42. The fill channel 44 of one barrel 35 may be connected to tubingline 41 which may be in fluid connection to fluid source 23 (saline,contrast, and other fluid being injected) or a fill chamber 90. Forexample, barrel 35 containing saline may have fill channel 44 fluidlyconnected to tubing line 41 which is in direct fluid communication withsaline source. Alternatively, the fill channel 44 of other barrel 35,such as barrel 35 containing contrast fluid, may be in fluidcommunication with connection tube 107 which in turn is in fluidcommunication with fill chamber outlet port 97, as described in moredetail below. The injection channel 39 may be connected to injectiontubing 47.

The valve 45 must be able to withstand high pressures during injectionof fluids. The Y-shaped valve 45 as shown may have angles up to onehundred and twenty degrees between the fill channel 44, injectionchannel 38, and barrel channel 48. This valve 45 design is animprovement upon valves commonly used in the art, which may be known as“T-valves” or “90 degree valves” which have ports separated by onlyninety degrees. An advantage of valve 45 is to maximize the ceilingsurface area between fluid paths over a traditional ninety degree valve.For example, the Y-shaped valve 45 is an increase of the ceiling surfacearea between first port barrel channel 48 and injection channel 38 andbetween fill channel 44 and barrel channel 48 because each port isseparated by at least one hundred and twenty degrees. This greaterceiling surface provides superior protection against valve 45 failureduring high pressure injections because stress on the valve may be moreevenly dispersed. Also, unlike a traditional T-shaped or ninety degreevalve, which may require fluid to take a sharp ninety degree turn duringan injection, the Y-shaped valve 45 may provide for a less severe andsmoother transition or turn for fluid to travel. Thus, Y-shaped valve 45has less of a chance for leaking, cracking, or failure during highpressure fluid flow because stress on valve 45 is more evenlydistributed and flow of fluid is less turbulent.

The valve 45 has an injection setting, a fill setting, or a closedsetting. The movement of the tab 46 controls changing between thesettings. The tab 46 is controlled by the valve actuator 16 (see FIG. 3a), which in turn is controlled by the user interface 7. As the userselects a certain function on the interface 7 this causes the valveactuator 16 to automatically rotate. As the actuator 16 rotates thiscauses the tab 46 to simultaneously rotate, thereby changing the valvesetting. As seen in FIG. 13, the valve 45 is shown in the injectionposition with open fluid communication between the barrel channel 48 andthe injection channel 38. The injection position allows for fluid to beinjected into the patient by establishing a flow path from the barrel 35through the injection channel 48 to the injection tubing 47 which is influid communication with fitting and single-use subassembly. As seen inFIG. 14, the valve 45 is in the fill position with open fluidcommunication between the fill channel 44 and barrel chamber. The fillposition is used to fill the barrel chamber by allowing fluid to travelfrom the fluid source 23 or fill chamber 90 into the barrel 35 and mayalso be used during venting. As seen in FIG. 15, the valve 45 is in aclosed position with no open fluid communication between any of theports. A closed position may be used when the single-use subassemblyneeds to be changed or when injector is shut down for an extended time.

Referring to FIGS. 11 and 16-18, the multi-use subassembly also includesa venting system 43 used to purge barrel 35 of trapped or unwanted air.The injection system must be primed before use to avoid any air beinginjected into the patient. The priming stage includes filling thesyringe barrel 35 of the multi-use subassembly 3 with fluid from thefluid reservoirs and then filling the single-use subassembly with fluid.During priming air may become trapped within the syringe barrel 35 or inany the fluid lines, therefore it is important to remove this airthrough the venting system 43 prior to injecting fluid into the patient.

The venting system 43 comprises a fill chamber having a top half 91 andbottom half 92, the fill chamber may have several ports including: aninlet port 99, an outlet port 97, and an overflow port 95. Ventingsystem may also include a waste chamber 96 having a top half 94 andbottom half 93, and several ports including a first inlet port 101, asecond inlet port 103, a third inlet port 105, and an outlet port 117.

The fill chamber may be used to fill one of the syringe barrels 35 withfluid, such as contrast, and prevent back pressure buildup within thefluid source. It is common for contrast fluid sources to be packaged inhard glass medical grade containers that may be susceptible to a buildupof reverse or negative pressure leading to leaks or cracking in thefluid connection. For example, if the barrel 35 containing contrast wasin direct fluid communication with contrast source then during thepurging sequence pressure from the syringe barrel 35 may build andtravel back up stream towards the contrast fluid source. Since thecontrast fluid source may be a hard glass container that does not allowfor expansion, any buildup of negative pressure may lead to leaks ordamaging the fluid connection between the injector and contrast source.Therefore, the fill chamber 91 acts as a pressure release or pressurebuffer to prevent the unwanted pressure buildup within the contrastfluid source. Conversely, the saline fluid source is commonly packagedin a flexible medical grade pouch or bag that is expandable and able towithstand reverse or negative pressure without causing leakage orfailure in fluid connections. Therefore, it is possible for the barrel35 containing saline to be in direct fluid communication with salinesource because any negative pressure during purging will simply expandthe flexible saline bag and not impact the connections between salinesource and injector.

To more clearly understand the function of the fill chamber the processof filling the barrel 35 with contrast will now be described in detail.As seen in FIG. 17, the fill line 41 for fluid source, preferablycontrast, is connected to the fill chamber inlet port 99 having aone-way check valve 116. As the plunger 36 of the contrast barrel 35retracts back during the venting sequence, as described in more detailbelow, negative pressure is created within the barrel 35. The negativepressure draws and pulls the contrast from its source along the filltubing 41 before passing through the fill one-way check valve 116 andinto the fill chamber 92. The negative pressure within barrel 35 willpull or force contrast collected within fill chamber to pass through thefill chamber outlet port 97, through a connection tube 107 into thevalve fill channel 45 and then through first port 55 into the barrel 35,as seen in FIG. 12. Referring back to FIG. 17, the inlet port 99 mayhave a standard one-way check valve 116 preventing air from exiting theinlet port 99 and traveling back up line towards the contrast source,thereby preventing the unwanted buildup of negative pressure within thecontrast fluid source. During venting it may be necessary for any excesscontrast in the fill chamber 92 to be forced through the fill chamberoverflow port 95 and one-way check valve 115 then along the overflowconnection tube 109 and into the first inlet port 101 of waste chamber96. The reason the excess contrast will back flow through the fillchamber overflow port 95 rather than through the fill line 41 to thecontrast fluid source is because the one-way check valve 116 preventsreverse flow from the fill chamber 92 to fluid sources, therebyprotecting against additional waste of the entire fluid source.

The waste chamber 96 is intended to allow air to escape from the barrelwhile also collecting any saline, contrast, or other fluid that isremoved during the purging process. If the injector 1 is tilted at arange of 5-40 degrees relative to the horizontal axis of the base, asshown in FIG. 2, any air remaining within barrel will be forced to thetop rear of the syringe barrel 35, near the location of the second port57. Referring to FIG. 16, air is forced through the second port 57 ofbarrel 35, through a waste one-way check valve 113(a), 113(b) alongwaste connection tubing 111(a), 111(b) and then into either the second103 or third 105 waste chamber inlet ports. Then excess air passesthrough the waste chamber outlet port 117 which is open to atmosphere.The waste chamber outlet port 117 may have a standard one-way checkvalve 118, as shown in FIG. 17, to only allow air to escape from thewaste chamber 96 and prevent unwanted air from entering the systemthrough the outlet port 117.

The waste chamber 96 may contain multiple fluid columns 119 to increasethe total surface area of the waste chamber 96, as seen in FIG. 18. Thepurpose of the multiple fluid columns 119 is to increase the overallsurface area of the waste chamber 96 while thereby increasing the amountof fluid the waste chamber 96 is able to hold without increasing theoverall size of the waste chamber 96. The fluid columns 119 increaseoverall distance the fluid must travel before it enters the wastechamber 96, thereby increasing total waste capacity without increasingthe size of the waste chamber 96. As fluid enters the waste chamber itmust travel up and down each fluid column 119 before it actually entersthe chamber and collects along the bottom surface 93.

During the automated injection sequence the system may stop plungerbefore it reaches the front end 51 of barrel 35, thereby leaving areservoir of predetermined volume of fluid (5-10 mL) within barrelchamber captured between the plunger and the front end 51 of the barrel35, as seen in step 123 of FIG. 19. The purpose of this reservoir ofpredetermined volume of fluid is if any excess air is trapped insidebarrel chamber after purging the air will be forced along the top wall56 of the barrel 35 because injector housing 13 may be tilted at a 5-40degree angle along the horizontal axis.

As seen in FIG. 19, the method of injecting fluid into a hollowanatomical structure using the injector system disclosed herein mayinclude several steps. The movement of air or fluid inside the barrel 35chamber is controlled by the movement of the plunger 36. The movement ofthe plunger 36 may be controlled by the injector ram. For example, theplunger securement nub 34 may be securely attached to the rear supportmeans and in turn the injector ram, as described in more detail below,so plunger movement is controlled as injector ram advances forward orretracts back. The purging sequence 121 may start with plunger 36 atproximal most end of barrel 35 and the valve 45 is rotated into theinject position, as seen in FIG. 13, so the barrel channel 48 is influid communication with the injection channel 38. The barrels 35 may bepurged prior to being connected to the procedure catheter. Next, plunger36 is pushed forward 123 towards front of barrel 35 causing any trappedair in barrel 35 to be expelled through first port 55 and through valve45 and tubing 47 and then fitting 133, as also seen in FIG. 12, which isopen to atmosphere. Next, the valve 45 is rotated to fill position, asseen in FIG. 14, so the barrel channel 48 is in fluid communication withthe fill channel 44. Plunger 36 is then retracted to a first purgeposition 127 which is a first selected distance proximal from the secondport 57. While plunger 36 is in first purge position 127 fluid may befilling the syringe barrel 35 through port 55. The rate at which fluidfills syringe barrel 35 depends on the fluid's viscosity, for examplecontrast may take a longer time to fill syringe barrel 35 than salinedue to contrast's higher viscosity. Once fluid has filled the syringebarrel 35 the plunger 36 may be advanced forward slightly to a secondpurge position 129 a second selected distance proximal from second port57. While plunger 36 is in second purge position 129 any trapped airstill remaining in barrel 35 will be forced out of barrel 35 throughsecond port 57. After all air has been removed the valve 45 is rotatedinto the inject position, as seen in FIG. 13, and the plunger 36 isadvanced distally beyond the second port 57 to the inject position 130.During injection, plunger 36 is advanced distally causing fluid to beadvanced through port 55 into lines 47, as show in FIG. 12. Afterinjection is complete 132 the user may select to either refill thebarrel 35 or put the injector in standby mode. If the user elects torefill the barrel 35 then the valve 45 may be rotated to fill position,as seen in FIG. 14, and injector would repeat fill and purge steps 123,127, 129 and 130. Alternatively, if user elects to put injector instandby mode then valve 45 may be moved to closed or off position, asseen in FIG. 15. Standby mode may be used between procedures of multiplepatients or if the injector is not going to be used for an extendedperiod of time.

As seen in FIGS. 20-23, the injector system 1 may comprise a rear barrelsupport means 79. The purpose of the rear barrel support means 79 is tosecurely attach and hold the securement ridge 59 of barrel 35 to theinjector housing 13. The rear barrel support means 79 may comprisemultiple support flanges 85, 83, a plunger lock means 88, and a topflange (not shown). The rear barrel support means 79 may be part of theinjector housing 13 and adjacent to the injector rams 15.

The injector rams 15 may be a mechanism capable of advancing andwithdrawing the plunger inside the barrel chamber. The injector rams 15may be mechanical arms or pistons that push and retract the plunger 36of barrel 35. For example, in this embodiment the injector rams 15 maybe motorized pistons that are advanced forward toward the front face ofthe barrel during an injection and are withdrawn back towards rearsupport means 79 during a fill or purge sequence. The movement of theinjector rams 15 may be controlled by electronic signals sent fromeither the user interface or the hand controller. For example, the usermay input injection parameters into the user interface or choosedifferent selections on hand controller and then an electronic signal issent from user interface or hand controller to the injector rams 15.Depending on the type of electronic signal sent the movement of theinjector rams 15 may be either forward or rearward. The injector rams 15may include a sensor 87 to measure how much force or pressure is beingtransferred to the plunger 36 as the plunger 36 is moved forward andrearward. The ram sensor 87 may measure the amount of force exerted ontothe barrel 35 by the rams 15. The ram sensor 87 may be comprised of aknown sensor in the art. This sensor 87 is in electronic communicationwith the user interface 7. The interface 7 uses the information fromsensor 87 to measure at what pressure or force the injector is operatingand ensuring this is correctly correlated with the user inputs.

The support flanges may include, but not limited to, a top flange (notshown), at least one bottom flange 83, and at least two side flanges 85.If a top flange (not shown) is used, it may be connected to supportmeans 79 via a hinge so during setup the top flange is able to be liftedup and away from the side flanges 85 and bottom flange 83. The flanges83, 85 are intended to be shaped and size to securely enclose thesecurement ridge 59 of barrel 35, as shown in FIG. 20. The flanges 83,85 may have a barrel groove 86 and a shell groove 82. Grooves 82, 86 mayconsist of an indent or step along the ends of the flanges 83, 85. Thesides of the securement ridge 59 may align with and be slid into theridge grooves 86 of the side flanges 85. Additionally, the shell 61 mayhave a rear ridge 28 that securely fits within shell groove 82. Thebottom flange 83 may also have a groove 80 that aligns with the bottomof the securement ridge 59. In addition to flanges for support, the rearbarrel support means 79 may also include a plunger lock means 88. Theplunger lock means 88 is intended to securely attach to the plungersecurement nub 34 on the rear end of the plunger body 37. The lock means88 may have a notch 84 that is shaped to receive the securement nub 34.

As seen in FIG. 22-23A, the rear support means 79 is intended tosimplify system setup. The system allows the user to simply align thesecurement ridge 59 over the rear barrel support means 79 and then pushthe multi-use subassembly 3 in place. First, the user may hold onto theside tabs 68 of shell 61 and align the securement ridge 59 with ridgegrooved 86 and shell ridge 28 with shell groove 82 of side flanges 85.Next, the multi-use subassembly may be push downward to align theplunger securement nub 34 with the notch 84 of the plunger lock means88. Finally, the user may continue to push down on the multi-usesubassembly 3 until the bottom side of the securement ridge 59 isaligned with the grooved 80 of bottom flange 83. An advantage of therear support means is that once the user aligns the securement ridge 59with the rear barrel support means 79 all of the other components of themulti-use subassembly 3 are automatically align into proper positionmaking the setup process faster and overall injector more user friendly.For example, once the securement ridge 59 is over the rear barrelsupport means 79 the valve tabs 46 will also be aligned over the valveactuator 16. Upon proper placement of the multi-use subassembly 3 intothe rear barrel support means 79 the user may hear an audio feedback,such as a sound or a “click”, or have a tactile feedback response. Aftermulti-use subassembly 3 has been positioned inside the rear barrelsupport means 79 the user may push down or close the top flange (notshown) or the cover 6, thereby locking and securing the multi-usesubassembly 3 to the injector.

As seen in FIG. 23B, the shell ridge 28 may further comprise a liftsupport 29. The lift support 29 provides the user with a means forlifting the shell 61 from the injector housing. For example, after ahigh powered injection the shell 61 may be difficult to remove andreplace. Therefore, the life support 29 may provide the user with anadditional area to grasp onto and assist the user with faster removal ofthe shell. The lift support 29 may be a separate piece of material thatis securely attached to the shell ridge 28 by ordinary means known inthe art. The lift support 29 may take the form of a ring, key hole,circle, or other shape that allows a user to easily grasp onto.

Referring now to FIG. 24-27, the multi-use subassembly 3 and single-usesubassembly 5 may be connected by a specially designed fitting 133. Itis known in the art to use standard luer type connectors for injectionsystems. Such standard luer connections require the user to twist orrotate a luer at each connection point. The purpose of the fitting 133for this injection system is to allow the user to quickly connect themulti-use assembly to the single-use assembly. The connection makes thesetup simpler, more reliable, and decreases overall setup time. Ratherthan using standard luer type connection the injection system may use aspecially designed “snap fit” or “quick connect” fitting 133 to connectthe multi-use subassembly 3 and the single-use subassembly 5. Thefitting 133 may also comprise a dust cap or other protective means forpreventing contamination of the fluid lines.

As seen in FIG. 24, the fitting 133 may comprise of a multi-useconnector 137 and a single-use connector 139. The multi-use connector137 may be attached to the multi-use connector 137 which is in fluidcommunication with the barrel, as seen in FIG. 12. The single-useconnector 139 may be attached to the single use tubing set 209, as seenin FIG. 28. The multi-use connector 137 may have securement grooves 141,alignment ridge 143, and female tubing connections 145. The single-useconnector 139 may have securement tabs 147, alignment ridge 148, maletubing connections 149, tubing seals 153, and an anti-rotation means151. The alignment ridges 143, 148 are designed to provide the user withtactile surface when grasping the fitting 133. The alignment ridges 143of multi-use connector 137 and the alignment ridge 148 of the single-useconnector 139 may both have convex, concave, or other mirrored shapes sothe user knows by touch or feel that the connectors 137, 139 areproperly aligned when connected. The male tubing connections 149 maycomprise a tubing seals 153, such as a standard O-ring, to preventleaking and ensure a fluid tight seals within the fitting 133. Theanti-rotation means 151 may be comprised of an additional protrusion orflange extending from the single-use connector 139 that aligns with aslot (not shown) in the multi-use connector 137. The purpose of theanti-rotation means 151 is to provide additional connective support orstructure to fitting 133 and prevent unwanted twisting or rotationduring high pressure injections.

During use, the user may use the curvature of the alignment ridges 143,148 to provide tactile feedback that the single-use connector 139 andmulti-use connector 137 are properly aligned. As the user pushes theconnectors 137, 139 together the male tubing connection 149 willautomatically align with the female tubing connection 145 creating atactile and audio feedback; similarly the anti-rotation means 151automatically slides within corresponding slot in multi-use connector137. The securement tabs 147 of the single-use connector 139 slide alongthe securement grooves 144 of the multi-use connector 137 until the userhears a “click” sound and feels a haptic response that the fitting 133has been properly connected. To disconnect the fitting 133 the usersimply needs to push the tabs 147 in towards the center of the fitting133 and the pull apart the connectors 137, 139. In an alternativeembodiment, the securely tabs 147 may comprise a foot 142 having a notch(not shown). The notch may align with a corresponding tab or extension(not shown) protruding within securement grooves 141 of the multi-useconnector 137. When securement tabs 147 are aligned with securementgrooves 141 and are pushed together the notch on foot 142 may fit withinthe protruding tab or extension. This notch and groove fitting mayprovide additional connective support or structure to fitting byeliminating twisting or rotational movement of the foot 142 and tab 147.

FIG. 25-27 illustrates the placement of the connection 133 within thehousing base 153. House base 153 extends from the injector housing andis used to securely hold the fitting 133 and air sensor 155. Housingbase 153 may comprise a seat for the fitting 133, a seat for an airsensor 155, a housing door 157, a viewing window 159, and a lockingclamp 161. The purpose of the viewing window 159 is to provide user withvisibility of the fitting 133 connection during use. The air sensor 155may be standard bubble detectors as known in the art and may useultrasound to detect small amounts of air trapped in tubing 209 ofsingle-use subassembly. If air is detected by sensor 155 in system afterpurging is complete interface 7 may automatically stop injection toprevent air from being injected into patient. The sensors 155 mayinclude tubing channels 144 to permit proper placement of the single usetubing 209. The housing door 157 may include raised bumps 158 along theinside wall of the door 157. These bumps 158 are designed to align withthe tubing channels of the sensor 155 so when the door 157 is closed andin a locked position the bumps 158 ensure the single use tubing 209remain securely inside slots 144 ensuring the sensors 155 obtain anaccurate reading.

The housing door 157 may be connected to housing base 153 via a hingedconnector 163 that allows the door 157 to swing open and close. Whendoor 157 is in an open position the fitting 133 may be placed into base153 and single patient tubing 209 may be placed into air sensor 155slots 144. After fitting 133 is properly in place the door 157 may beclosed and securely locked to base 153 using the clamp 161. The clamp161 may also be connected to base 153 via a hinged connection 165. Theclamp 161 may include a locking means 167 that is connected to the clamp161 via another hinged connection 169. When the clamp 161 is hinged orpulled upwards into an open position, as seen in FIG. 26, the lockingmeans 167 may align with a notch 171 on the top surface of the housingdoor 157. As the clamp 161 is pushed downwards the locking means 167grasps along the door notch 171 and securely locks the door 157 to thebase 153, as seen in FIG. 27.

As seen in FIGS. 28-31, the injector system includes a single-usedisposable subassembly 5. This single-use subassembly 5 is intended toconnect the multi-use subassembly 3 with the procedure catheter (notshown) via fitting 133. The single-use subassembly 5 may comprise asingle-use connection 139, pressure transducer 203, pressure monitoringline 205, pressure protection valve 207, co-extruded high pressuretubing 209, a tubing junction 211, high pressure tubing 213, a distalhigh pressure stopcock 215, catheter connection tubing 217, and aprocedure catheter connection 219. An advantage of using the single-usesubassembly 5 is to eliminate the risk of infection or contamination ofthe multi-use subassembly 3. An advantage of single-use 5 subassembly isit may be detached and discarded after each patient, whereas multi-usesubassembly may be used for multiple patients, saving user both time andmoney.

The single-use connection 139 is connected to and in fluid communicationwith co-extruded high pressure tubing 209 which is able to withstandinjection pressure of at least 1,400 psi. Tubing 209 may be aco-extruded dual lumen fused component designed to avoid tangling ofindividual lines. Proximal end of tubing 209 may be aligned with airsensor 155 to prevent unwanted air being injected into patient. Distalend of tubing 209 is connected to and in fluid communication with atubing junction 211. The tubing junction 211 is connected to and influid communication with both a pressure protection valve 207 and singlelumen high pressure braided tubing 213 rated up to at least 1,400 psi.The high pressure braided tubing 213 is connected to and in fluidcommunication with a distal high pressure stopcock 215. The stopcock 215may be used to deliver fluids to the catheter, draw blood samples, orremove waste from the system.

The single-use 5 subassembly is able to mix contrast and saline in-line.The co-extruded dual lumen tubing 209 may have separate lumens forcontrast fluid and saline fluid. When the co-extruded dual lumen tubing209 reaches the tubing junction 211 it is at this point that the salinefluid and contrast fluid may be mixed together into the single lumenhigh pressure braided tubing 213 to form a diluted or mixed solution.For example, if user elects to inject a solution having the ratio of 50%contrast and 50% saline then equal amounts of contrast and saline willbe injected from the barrels of multi-use subassembly and travel alongthe co-extruded dual lumen tubing 209 until the fluids reach tubingjunction 211 at which point the two fluids may mix together to form adiluted solution. Alternatively, the user may inject a highly dilutedcontrast solution, such as 20% contrast and 80% saline, and still beable to achieve high quality images. An advantage of this system isproviding the user the able to dilute contrast fluid and still achievehigh quality images. Therefore, diluting contrast being injected intothe patient with a mixture of saline means less contrast solution may beused during a procedure, and over time this can lead to huge savings inboth wasted contrast and money spent on contrast.

These various tubing junctions and connections between differentcomponents of the single-use disposable subassembly 6, together with themulti-use subassembly 3, may be permanently secured by various methodsknown in the art, including, but not limited to, UV bonding, adhesivematerial, or ultrasound bonding, and intended to withstand injectingpressures of at least 1,500 psi.

The pressure protection valve 207, pressure monitoring line 205 andpressure transducer 203, are described in U.S. Pat. No. 6,896,002,entitled PRESSURE TRANSDUCER PROTECTION VALVE, and U.S. Pat. No.6,986,742, entitled PRESSURE TRANSDUCER PROTECTION VALVE, and both areincorporated herein by reference. The pressure protection valve 207 isintended for a two-way connection and fluid communication between tubingjunction 211 and a disposable pressure transducer 203. Pressuretransducer measures the patient's blood pressure.

Referring to FIGS. 30-31, the pressure protection valve 207 includes acap 221, a flexible diaphragm 223, a stem 225, a sealing surface 227, abody 229, a housing 231, source fluid channel 233 and a pressuretransducer tubing connection. The pressure protection valve 207 isactivated when a pressure fluctuation exists between source fluidchannel 233 and a pressure transducer tubing connection 235 causing thecompliant flexible diaphragm 223 to deflect away from its originalposition towards the channel 233. The top of the integrated stem 225 isconnected to the diaphragm 223 and the bottom of the stem 225 isconnected to the body 229. The deflection of the diaphragm 223 moves theintegrated stem 225 away from the channel 233, causing the body 229 toengage a sealing surface 227 and create pressure isolation betweenchannel 233 and disposable transducer 203. This seal protects thedisposable transducer 203 from excessive pressure which may damage orimpact the transducer 203. The pressure protection valve 207 may createa seal to protect transducer 203 before fluid pressure in channelreaches a pressure sufficient to damage the transducer. Once pressure offluid flow through channel 223 is lowered the diaphragm 223 moves backto its original position, thereby separating the body 229 from thesealing surface 227 and re-establishing or opening fluid communicationbetween the transducer 203 and channel 223.

In yet another embodiment of this invention, there may be a need in theart for both the single-use subassembly 5 and multi-use subassembly 3 tobe single patient use only. For example, if the fluid source 23, such asthe contrast container, is indicated as a single use only then eachcomponent of the injector that contacts the fluid may need to be changedafter each use. In this embodiment, the components of both thesingle-use subassembly 5 and multi-use subassembly 5 may remain the sameas above except for the fitting 133. In place of the quick connect orsnap fit fitting 133 of the previous embodiment, this embodiment may usea standard luer type connection as known in the art or be directlybonded together. The standard fitting connection would fluidly connectthe injector tubing 47 of the multi-use subassembly and the proximal endof tubing 210 of the single-use subassembly 5.

As is shown in FIGS. 32-34, a controller 9 of the invention may includea handle 300, a front actuator 301, rear flush button 302, a selector303 for selecting a fluid source from which to inject fluid within apatient, a puff button 307 for injection of a small controlled amount offluid, and a visual identifier 309 to notify user of the type of fluidselected to inject. Controller 9 may also include various internalcomponents including, but not limited to, a tactile feedback means 311for providing a tactile or haptic response, and a sensor 313 formeasuring position of actuator 301. The rear flush button 302 may beused to inject a predetermined amount of fluid, such as saline, to flushthe system or procedure catheter. Controller 9 may be used to controlthe start and stop of injections, flush the tubing lines, deliver a“puff” or selected amount of contrast, select the type of fluid to beinjected into the patient, and warn the user when an injection may bedangerous to the patient or system.

FIG. 32 depicts a controller 9 according to certain embodiments of theinvention. The controller 9 communicates with the user interface 7 viacontrol cable 305. In certain embodiments, the controller 9 can beconnected and disconnected from the control cable 305 via a firstconnector (not shown) that matches up to a second connector (not shown)on the cable 305. The connection between the first and second connectorscan be made using any suitable connection means known in the art, forexample male and female mini-DIN connectors. Alternatively, in certainembodiments, the controller 9 communicates wirelessly with userinterface 7. Any suitable wireless protocol may be used in theinvention, including 802.11(a, b, g, or n) and any other suitableprotocols used in the art. In certain embodiments, the controller 9 maybe connected to user interface 7 via a network connection, includingover the internet. Accordingly, in certain embodiments, controller 9includes hardware and/or software for transmitting and receiving signalsover a network, including wirelessly.

Controller 9 is, in certain embodiments, composed of materials that canbe sterilized once or more than once, for example by autoclaving,irradiation, or alcohol swab or immersion, or may be kept sterile duringthe procedure by placing a protective disposable sleeve over controller9 during use.

The front actuator 301 may have a finite distance to travel within thecontroller 9. The user may move or press down on the front actuator 301in order to cause a corresponding movement of fluid between theinjection system and a patient. The depression of the actuator 301 maysend an electronic signal to either the user interface or the injector.The relationship between how much the user moves the front actuator 301and the quantity of fluid that is infused into a patient may be anyuseful or advantageous relationship, and may depend upon, among otherthings, the application for which the automated fluid management systemis used, the injection mechanism employed by the automated fluidmanagement system, the inputs user selected on the user interface 7, orthe preference or selection of the user. In certain embodiments, themapping between the amount a user moves the front actuator 301 and thequantity of fluid infused is linear (i.e. the transfer function islinear), advantageously permitting the controller to function similarlyto an infusion syringe and in a manner that is familiar to physiciansand easier to learn. In other embodiments, the mapping between theamount of movement of the front actuator 301 and the quantity infused isnon-linear (i.e. the transfer function is nonlinear), permitting thetailoring of fluid delivery to specific uses. For example, if a highpower injection of contrast agent is desired, the mapping may be linearover a portion of the travel of the front actuator 301, then exponentialover another portion, then linear again.

The controller 9 also includes a selector 303 for selecting one of aplurality of fluid reservoirs within the automated fluid managementsystem from which to infuse fluid into a patient or into which todeposit fluid from a patient. In preferred embodiments, the injectorsystem includes reservoirs for saline and contrast, and the selectorpermits users to select one of these reservoirs or a mixture of bothreservoirs that are mixed inline during fluid delivery.

Controller 9 may provide the user with feedback as to the status of apatient or the automated fluid management system. Feedback may be sentto and received by user in various forms including, but not limited to,audio feedback, visual feedback 309, such as LEDs or flashing lights,tactile or haptic such as resistance in front actuator 301 orvibrations. In one embodiment, front actuator 301 provides the user withposition-based feedback as to the level of fluid in the barrel 35 of themulti-use subassembly 3 selected with the selector. The front actuator301 has a finite travel within the controller, and the position of theactuator along its travel corresponds to the fluid level within theselected barrel 35. The fluid level can be measured in absolute terms,for example in mL, or in relative terms, e.g. percent fullness. Incertain embodiments, the fluid level in the barrel 35 maps linearly tothe position of the front actuator 301 along its travel, i.e. thetransfer function is a linear function. These embodiments permit a userof the controller 9 to receive tactile or haptic feedback from theactuator 301 in a manner similar to the plunger of an infusion syringein a manual injection system known in the art. For example, tactile orhaptic feedback may be felt if distal end of catheter is occludedpreventing fluid to flow from injector. These embodiments mayadvantageously permit new users to rapidly learn how to use controllers9 of the invention. However, in other embodiments the fluid level willmap in a non-linear (e.g. exponential) manner, i.e. the transferfunction is non-linear. These embodiments may permit users ofcontrollers to tailor the feedback information provided by the actuatorto specific applications.

In certain embodiments, the position of the front actuator 301 and thedegree of movement map to fluid level and fluid displacement,respectively, in the same way. For example, the controller 9 may beconfigured to behave as a 10 cc syringe, so that movement of theactuator 301 along 10% of its total travel results in the infusion of 1cc of fluid into or out of a patient, and when the actuator 301 ispositioned at the midpoint of its travel, the selected barrel 35 willcontain 5 ml of fluid. It should be noted that, in an embodiment such asthis one, after a user moves the front actuator 301 to cause fluid to beinfused into a patient, the user may let go of the front actuator 301and the it will remain in the position in which the user left it. Inother embodiments, however, the mapping of the fluid level in theselected reservoir to the position of the front actuator 301 for theprovision of feedback may be different than the mapping of the positionof the front actuator 301 to the amount of fluid that is infused into apatient. In these embodiments, after the user releases the frontactuator 301, or after the user has stopped applying force to the frontactuator 301, the actuator 301 changes position based on the fluid levelwithin the selected barrel to provide position-based feedback of fluidlevels. In other embodiments the position of the front actuator 301 andthe degree of movement map to velocity based control. For example, thecontroller 9 may be configured so that at rest and no movement equalszero velocity and full depression on front actuator 301 equates to fullvelocity of injection. The velocity is based off of flow rates, so ifthe maximum flow rate is set at 5 mL/sec when front actuator 301 iscompletely depressed fluid is delivered at the maximum flow rate of 5mL/sec.

The front actuator 301 of the controller may provide feedback in otherways and for other parameters. In certain embodiments, in addition toproviding position-based feedback to users, the front actuator 301 alsoprovides resistance-based feedback to users. The resistance-basedfeedback may in the form of vibrations, resistance in movement of thefront actuator 301, or providing the user with a haptic response such asshaking or jarring of the controller 9. The haptic or tactile feedback,such as vibrations, shaking, or jarring of controller 9, may begenerated by the tactile feedback means 311 as seen in FIG. 34.Preferably, resistance based feedback is provided based on a level offluid pressure within the injector system. For example, the fontactuator 301 may resist movement from rest to a relatively high degree,or the controller 9 may begin to vibrate, if the fluid pressure isrelatively high within the injector system. For example, if injectionbegins to approach max pressure limits, the vibrations may increase infrequency and/or intensity. Similarly, front actuator 301 may resistmovement from rest very little or not at all, or the controller 9 maybegin to vibrate, if the fluid pressure is relatively low. The degree ofresistance may be determined by the controller based on relativepressure values or absolute pressure values and, as discussed above, themapping between pressure and resistance applied may be linear ornon-linear. For instance, in certain embodiments, the resistance may beset to a maximum when the pressure reaches or exceeds a certain value,and may be set to zero when the pressure reaches or drops below anothervalue, advantageously mimicking the kind of resistance provided by astandard infusion syringe and catheter set-up, which is familiar tophysicians and easy to learn. Alternatively, the resistance may be zerobelow a particular threshold value, then maximum above that thresholdvalue.

In certain embodiments, the controller 9 provides additional orsecondary feedback via other mechanisms, including visual identifiers309 including LEDs or display screens, and audio feedback includingaudible alerts.

Controller 9 of the invention can be made any suitable size or shape,and have any suitable actuator mechanism. Controllers 9, actuator 301,and selector 303 may have any suitable form factors. For example,actuators 301 may be made in form factors including plungers, joysticks,rocker switches, toggle switches, paired buttons, scissor handles,trackballs, computer mice, touch wheels, scroll wheels, etc.

In one embodiment (not shown) the controller 9 may have a form factorresembling infusion syringes generally used in the art. It includesmultiple ergonomic finger holes into which a user can place fingers orthumbs to advantageously achieve comfortable leverage over the actuator301. The actuator 301 may be shaped like a syringe plunger, and isoperated in a manner similar to the plunger of an infusion syringe: theactuator 301 is pushed inward to cause the system in infuses fluid froma reservoir into a patient.

In yet another embodiment of the controller 9, as seen in FIG. 32, thefront actuator 301 may be a depressible button. Controller 9 once againincludes a handle 300 optionally ergonomically shaped, permitting usersto grip the handle 300 with their fingers and palm while operating theactuator 301, 302 and the selector 303. The front actuator 301 mayinclude a depressible button that may be operatively moveable by theuser's thumb. For example, the user may depress or press down on frontactuator 301 to cause infusion. The controller 9 may also have afinger-operated rear button actuator 302, as seen in FIG. 33. The rearbutton actuator 302 may be used in place or in conjunction with frontactuator 301, and may cause infusion when depressed by user. Theselector 303 preferably includes a button allowing user to choosevarious options for selecting saline, contrast, or mixture of both.Additionally, the controller 9 may have a puff button 307 that allowsthe user to inject a defined pre-set amount of fluid, contrast, salineor a mixture of both, every time it is pressed to help visualize wherethe catheter tip is located in the body. The actuators 301, 302 of thisembodiment may provide position-based feedback or resistance-basedfeedback as disclosed above. The feedback may be created by a motor orspring in the controller body that provides resistance to the actuator.For example, the actuator 301, 302 of this embodiment may be springloaded so that after being depressed by user the actuator is forced inan upward motion returning to its original state.

Referring now to FIGS. 35-40, the injector system may also include amounting system. The purpose of the mounting system is to assist theuser when transferring the injector housing 13 from a body unit 409 toanother surface. In many facilities that use an automated injectorsystem space is limited and many medical personnel are in the roomaround the injector. Therefore, an advantage of the mounting system isto assist the user in securing the injector housing 13 to a stationarysurface, such as a bed 410, wall mount, or ceiling mount, withoutobstructing the movement of the medical personnel in the room.

The bed mount 403 may include, but not limited to, rail connectors 413,mounting support 415, mount locks 417, mount brace 419, bed support 421,and adjustment means 423. The rail connectors 413 are designed tosecurely attach the bed mount 403 to the bed rails 411. It is understoodthat there are many different types or brands of hospital beds 410 andeach many have different sized rails 411, therefore it is an advantageof this invention that the rail connectors 413 may be adjustable andable to change sizes to fit various sized bed rails 411. Alternatively,rails connectors 413 may interchangeably fit with the same mountingsupports 415 allowing specialized rail connectors 413 to fit a singlebed mount 403. The mounting supports 415 are bars or arms that securelyconnect the rail connectors 413 with the actual bed support 421. The bedsupport 421 may be comprised of at least one flat bar or arm thatextends the width of the bed 410. The bed support 421 may also need tobe customized in order to fit various brands or sizes of hospital beds410, therefore the bed support 421 may have an adjustment means 423allowing the support to extend or retract for proper fitting. Theadjustment means 423 may be a series of screws or bolts that unlock toallow for the bed support 421 to either be extended or retracted andthen lock back in place thereby securing the bed support 421. The bedmount 403 may be securely attached to the bed 410 by using the mountlocks 417. Mount locks 417 may include, but not limited to, levers,screw locks, or other tightening locks known in the art. The mount brace419 is used to securely hold and embrace the mounting finger 14, asdescribed in more detail below.

To properly place the bed mount 403 the user may use the adjustmentmeans 423 to extend or retract the bed support 421 so it is properlysized to the bed 410. Next, the rail connectors 413 may be adjusted andslid onto the bed rails 411. The user may use the mounting locks 417 onthe rail connector 417 to securely attach the mount 403 to bed 410. Forexample, as seen in FIG. 37, the mounting locks 417 may include a knob419 and a locking plate 420. The knob 419 may be turned or rotated whichforces the locking plate 420 to move closer to the rail 411, therebysecuring the rail connector 413 to the rail 411.

After the mount 403 had been securely attached to the bed 410 the usermay then securely attached the injector housing 13 to the mount 403. Thetop of the connection arm 17 may be securely attached to the bottom ofthe injector housing 13 (see FIG. 2) and the bottom of the connectionarm 17 may be securely attached to the top of the mounting plate 407.The bottom of the mounting plate 407 may be connected to the top of thehousing base 405. The mounting plate 407 may have a mounting finger 14extending off its side. The mounting finger 14 is intended to be sizedto securely fit within slot 427 of the mounting brace 419. The mountingfinger 14 may have supports 433 extending from the housing base 405 toprovide lateral support to finger 14.

An advantage of this device is the cart 19, as seen in FIG. 2, may havea motorized body 409 or telescoping body, as known in the art, that canextends up and down. As seen in FIG. 40, the top wall 408 of themotorized body 409 may have a base finger 431 that extends into a slot(not shown) of the housing base 405. The base finger 431 may be securelyattached to base housing 405 via base locks 429, which may include, butnot limited to, levers, screw locks, or other tightening locks known inthe art. The user may use the motorized body 409 of the cart 19 to raisethe injector housing 13 so the mounting finger 14 is above the mountbrace 419. Since the cart 19 may have wheels the user may easily pushthe cart close to the bed 410 and effortlessly position the mountingfinger 14 in place so the tip of the finger 14 is aligned with slot 427of mounting brace 419, as seen in FIG. 38. Next, the user may lower themotorized body 409 of cart 19 thereby lowering the finger 14 intoposition so the entire finger 14 is captured within the mounting brace419, as seen in FIG. 39. Once the finger 14 is positioned inside thebrace 419 the user may use the injector locks 425 to securely fasten thefinger in place, thereby securing the injector housing 13 to the bedmount 403. After the injector housing 13 is secured to bed mount 403 theuser may unlock or loosen the base lock 429 so the motorized body 409 ofcart 19 may be lowered down even further, as seen in FIG. 40, completelyremoving the base finger 431 from the housing base 405.

Once removed, the cart 19 may be moved and stored away providing morefree space around the injector for doctors and nurses to walk and work.When the injector housing 13 needs to be moved to another bed the cart19 may be positioned so the base finger 431 aligns with slot (not shown)of housing base 405. The motorized body 409 may be raised and basefinger 431 extends fully into slot. User may secure housing base 405 tobody 409 by using the base locks 429. Next, user may unlock the injectorlocks 425 freeing the mounting plate 407 from the bed mount 403.Finally, user may continue to raise the motorized body 409 until themounting finger 14 is completely free of mount brace 419, allowing thecart 19 and injector housing 13 to be moved.

As seen in FIG. 41-56, the injector system may comprise of aninteractive user interface 7. The interface 7 is intended to control anddisplay various aspects of the injector including, but not limited to,setting injection parameters, automated purging of system, automatedinjection, displaying real time injection status, and providing a userfriendly interface. An advantage of user interface 7 may include asimplified setup procedure or simplified injection procedure. Theinterface 7 may provide step-by-step prompts or notices that areintended to guide the user through the simplified setup procedures orsimplified injection procedures. This simplified setup and injectionprocedure may decrease the learning curve compared to manual injectionsystems with manifolds or currently known automated systems. The purposeof the simplified setup procedure or simplified injection procedure isto minimize user interaction with system and automate as many featuresas possible. The simplified setup procedure may include, but is notlimited to, priming the system, steps for attaching the multi-use andsingle-use subassemblies, and venting the system. The simplifiedinjection procedure may include, but it not limited to, steps forinjection of fluids into a patient, auto refill of syringes, andchanging system sub-assemblies for the next patient case.

An advantage of minimizing user interaction and automation of systemfeatures is to save the user time and also reduce possible user error.Also, by automating certain features, such as priming the system,venting the system, and adjusting contrast to saline ratio, this mayminimize the amount of contrast or saline used, thereby decreasingoverall contrast waste. The interface 7 may be capable of fullautomation for certain features, however for safety concerns theinterface 7 may require user to confirm certain tasks have in fact beencompleted. For example, the interface 7 may be capable of fullyautomating the venting and air purging process, as described below inmore detail; however interface 7 may still require user to confirm theyhave visually inspected all fluid lines and syringes to ensure that noair is present. The purpose of the user confirmation is to provide anadditional level of patient safety but still saving user time byautomating the process.

Another advantage of interface 7 is to help user be able to adjustcontrast to saline mix ratio based on individual patient requirements inorder to minimize amount of contrast injected into the patient whileachieving clinically acceptable images. Reduction in amount of contrastinjected into a patient may help minimize potential for contrastincluded nephropathy (CIN). In addition, the interface 7 is intended tohelp user reduce the total contrast used during injection procedures,thereby resulting in total cost savings of over 25% in contrast relatedexpenses for the hospital or user. Another advantage of the interface 7system is the user has the ability to set patient specific injectionparameters, as described in more detail below, which may trigger warningmechanisms when fluid injection maximums have been reached.

The interface 7 may provide the user with multiple mounting options. Forexample, the interface 7 may be a touchscreen computer housed in adisplay unit 510 (see FIG. 2). The display unit 510 may be mounted onthe injector assembly housing 13 (as seen in FIG. 2) or attached to ahospital bed used for imaging. The display unit 510 may also be attachedto a movable arm 11 that folds onto itself to reduce injector footprintwhen being stored or not in use. The moveable arm 11 may be attached tothe injector assembly housing 13 (as seen in FIG. 2) or attached to ahospital bed used for imaging. If the display unit 510 is attached to amoveable arm 11 this may allow interface to be pulled across the patientbed or closer to the user for ease of use and be able to manipulatedisplay unit 510 at varying angles. The display unit 510 may be made ofplastics, metals, or various other materials known in the art. Thedisplay unit 510 may be capable of contacting various fluids, such aswater, saline, contrast, blood, and will withstand high temperatures,resist cracking or damage during normal usage. The display unit 510 maybe capable of being cleaned or disinfected with commonly used hospitalpractices.

For purposes of this application, the terms “code”, “software”,“program”, “application”, “software code”, “software module”, “module”,and “software program” are used interchangeably to mean softwareinstructions that are executable by a computer processor as known in theart. The “user” can be a physician or other medical professional.

The interface 7 may be in the form of software that is preloaded onto atouchscreen computer, an application that may be compatible with asmartphone or other portable device, or software that may be transferredonto a touchscreen computer, hospital network, PC or desktop computer.The interface 7 may have backlights that change in brightness so theuser can see the interface 7 in a dark room with little or no lighting.The brightness of the backlights may be changed manually by the user ormay automatically change depending on the amount of light in the room.The interface 7 may be powered by the injection system and also have abattery backup. The interface 7 may also have an electrical port (suchas a USB port as known in the art) or be connected to the internet(either wirelessly or being connected to an Ethernet cable) so thatinformation on the interface 7 may be exported or transferred to anothersystem. For example, the interface 7 may keep a history or summary ofinjections, as described in more detail below, and user may have abilityto copy this injection summary to a portable memory storage unit (suchas a USB) or transfer the injection summary over the internet orintranet.

In one embodiment, the interface 7 is on a touchscreen computer with adisplay screen. The user may control the interface 7 by manuallypressing tabs or buttons on the display screen, by remote control, by anapplication that is compatible with a smartphone or other portableelectronic device, or by voice commands. Tabs or buttons may change oralter its appearance to indicate to user that the tab or button has beenselected, for example the tabs or buttons upon selection may becomehighlighted, greyed out, blinking, flashing, or become a visual icon asknown in the art. The user may be able to calibrate the interface 7 tochange sensitivity levels of the touchscreen display so that system isable to detect the user's touch when wearing gloves, fluids (such ascontrast, saline, or blood) is on the screen, or user's hands havebecome wet. Alternatively, interface 7 may be voice activated orcontrolled via voice commands so instead of physically pressing a screenor tablet computer user may control interface 7 using a head set.

As seen in FIG. 41A, a schematic of one embodiment of the interface 7 isshown. The interface 7 may further comprise of an internal memory 502,data storage 504, and a processor 506 or CPU. The internal memory 502may be used to store user's inputs 500 or selections and transfer thisdata to the processor 506. Additionally, the user's inputs 500 may alsobe save in the data storage 504. The data storage 504 may be exported ortransferred via an external storage device, such as a USB device, orthrough an Ethernet cable. After the user's input 500 has been enteredand stored a processor 506 may then control the injection parameters 508of the injection system, as described in more detail below.

The interface 7 may also provide user with visual notifications. Forexample, the interface 7 software may have integrated visual statusnotifications that alert user when a change to the system has occurred.The integrated visual status notification may include flashing visualelements on the interface 7 screen, icons or pictures on the interface 7screen, an LED mounted on the interface 7 housing, or audionotifications. The visual notifications may be used to inform user thatthe disposable sub-assembly has been properly installed, visualizationof the syringes being filled or injected, the system has been armed, thesystem is injecting, the system has been disarmed, the system has beenarmed for high flow rate or high volume injections, or that the systemis approaching preset maximum flow rate or volume injections based onspecific patient criteria.

As seen in FIG. 41B, the start screen 501 is shown having a start tab503, recent cases tab 505, and a system status tab 507. The recent casetab 505 may include additional text or information about the previousinjections performed by the injector. For example, the recent cases tab505 may include statistics about the previous injections on the startscreen 501 and provide user with short summary of the previousinjections, such as time of each previous case and number of injections.If the user selects the recent cases tab 505 the display screen maytransition the interface 7 to a summary page, as described in moredetail below and seen on FIG. 53. The system status tab 507 may includeinformation about which part of the injection system is ready for theprocedure. The text in the system status tab 507 may be highlighted orbold to indicate that the particular subassembly has been properlysetup. Additionally, the user may be able to select the particularsubassembly listed on the status tab 507 to move directly to the setupscreen controlling that particular subassembly. Selecting the start tab503 may transition the interface to the setup screen 509, as seen inFIG. 42.

Referring now to FIG. 42, the setup screen 509 may comprise severalfunctional tabs, including but not limited to, a setup tab 511, a casetab 513, a summary tab 515, a settings tab 517, and a help tab 719. Whenthe setup tab 511 is selected, as shown in FIG. 42, the tab 511 maybecome highlighted, greyed out, blink, or otherwise visually indicate tothe user that the setup tab 511 has been selected. Upon selection of thesetup tab 511 the interface 7 begins a series of prompts to help guidethe user in setting up the injector system for use. The prompts may belisted in the check list box 521 containing the individual stepsrequired for properly setting up the injector system for a procedure.For example, the check list box 521 may include, but is not limited to;the following setup prompts, load shell and connect controls 523,connect fluid sources 525, and connect patient tubing 527. Additionally,each individual step may have a corresponding image box 513. The imagebox 513 may contain a picture, graphic, illustration, or other visualaid to help the user associate the particular step with the injectorsubassembly or component requiring setup.

Referring now to FIG. 43, if the user selects the load shell and connectcontrols 523 prompt the interface will next guide the user through aseries of steps as described in the flow chart. Each step in the flowchart may be a separate notice screen, popup window, or other visual aidthat is intended to guide the user through various steps in the correctsequence. The interface will prompt user to perform step or will notifyuser of a step automatically being performed by interface 7. Forexample, when the load shell and connect controls 523 prompt is selectedthe first step the interface may indicate the user to perform is openthe cover 529. After use has correctly opened the cover, the interfacewill instruct with the injector system to retract the pistons 531thereby simultaneously retracting the plungers which are connected tothe pistons. Once the pistons have been retracted the interface mayinform user to place shell 533 on the injector (as seen in FIG. 22-23A).Once the user has placed the shell 533 on the injector the system willcheck to determine if the shell sensor has been activated 535. The shellsensor (not shown) may be located on the injector housing and ensuresthat the user has correctly aligned and placed the shell or detect ifany fluid is in the shell. If the sensor fails to detect the presence ofthe shell the interface will notify user and inform user to remove andreplace shell 539. Alternatively, if the sensor detects the presence offluid in the shell the interface will notify user and inform user toremove and replace shell 539. After sensor has indicated shell isproperly in place the interface 7 may notify user to close cover 537 andtrigger injector to begin purging or removing air from shells 541. Asensor may detect closing the cover or securement of the latch.

Referring now to FIG. 44, if the user selects connect fluid sources 525prompt the interface may guide the user through a series of steps asdescribed in the flow chart. Each step in the flow chart may be aseparate notice screen, popup window, or other visual aid that isintended to guide the user through various steps. The interface maynotify user to access source fluid containers 545, then open spikestopcocks 547, and then specify sources 551. The sources may be eithersaline 549, contrast 553, or any other source (not shown). Once the typeof source is selected the user will be prompted to enter either a salinesource volume 555 or contrast source volume 559. User may enter volumebased on presets or patient specific parameters. After user has entereda source volume 555, 559 the user may select to fill syringe 557. Theinterface will automatically fill each syringe with the user selectedvolume. After syringes have been filled to selected volumes theinterface may trigger automatic venting of syringes 561 or alternativelythe user may manually select to vent syringes on interface (not shown).The system will check for air in syringes and if air is present 559 thesystem may repeat venting 561 until no air is present 656 at which timeinterface may notify user to connect patient tubing 557.

Referring now to FIG. 45, if the user selects the connect patient tubing527 prompt the interface may guide the user through a series of steps asdescribed in the flow chart. Each step in the flow chart may be aseparate notice screen, popup window, or other visual aid that isintended to guide the user through various steps. First the interfacemay notify the user to open the quick connect cover 563, then connectpatient tubing set to shell and depress tubing into bubble sensor 565,then close quick connect cover and secure latch 567. Once the system hasdetected the latch has been secured, for example detection by a sensor,the interface may prompt the user to indicate if the transducer is usedwith the tubing set 569. If a transducer is being used with the tubingset the interface may then prompt user or system to prime transducer571, open the stopcock on transducer 573, close the three-way stopcockon the injector 575, prime transducer line with saline 577, and checkfor air in the transducer line 579. If air is present in the transducerline 581 the interface may prompt user to manually re-prime transducerline until it is free of air 583. If no air is present in transducerline 585, or no transducer is being used with the tubing set, theinterface may then prompt system to prime the patient line 585, zerobalance the transducer with hemodynamics system 587, close the stopcockon transducer 589, close the three-way stopcock to transducer line 591,prime patient tubing line with saline 593, and determine if there is anyair in the patient tubing set 595. If air is present in tubing set 597,interface will prompt system to remove air from appropriate tubingline(s) by flushing saline and/or contrast 598. Once no air is presentin tubing line 596 the case is ready to start 599 upon users command.

Now referring to FIG. 46, after the injection system and single patienttubing set has been primed the interface may be prompted to help userselect the details on the case 600. User may select to start case 599and interface may prompt to set fluid maximums for patient 601. User mayinput contrast maximum 603 and saline maximum 605. For example, if thepatient suffers from contrast included nephropathy and can only safelywithstand a 50 mL of contrast fluid in a 24 hour period then theinterface 7 provides user with ability to set the maximum total volumeof contrast the system will inject during the procedure to be no morethan 50 mL. User may input volume with an onscreen keyboard thatindicates. Next, interface may prompt user to select initial proceduretype 607 by choosing a procedure 609. The interface may be preloadedwith various types of common procedures the injection system may be usedfor. The interface may provide user with an option of peripheral cases611, cardiac cases 615, physician case list 613 or other 617 cases.Cardiac cases 615 may include various preset injection parametersdepending on the specific type of case, for example interface may promptuser to select from aortagram presets 619, coronary presets 621, and aleft ventriculography presets 623. These are merely examples of the typeof cardiac preset parameters available to choose from, it is within thescope of this invention that additional procedures may be included inthe preset parameter options including, but not limited to, cardiac,catheterization, selective coronary angiography, coronary intervention,coronary angiogram, Chronic Total Occlusion, Transcatheter Aortic ValveReplacement (TAVI/TAVR), and coronary bypass graft angiography. Examplesof peripheral cases 611 may include, but not limited to, intravascularultrasound (IVUS), peripheral angiogram, endovascular aneurism repair,Y-90 mapping, CT cone beam studies, interventions, and any otherprocedure requiring X-ray imaging of the peripheral. The presetparameter options is intended to be guide for setting up the injectionsystem; each case is unique and may require specific injectionparameters so as described in more detail below the user will have theoption to change the preset parameters on the dashboard screen prior tostarting the case. The physician list 613 may include preset parametersfor various physicians using the injector system. Each physician mayhave unique preset case parameters that they wish to use as defaults.The physician list 613 presets may be changed or updated frequently.Alternatively, interface 7 may provide user an option to skip selectcase 609 and go directly to dashboard and manually enter injectionparameters.

Referring now to FIG. 47, the system may also include an auto refilloption. The purpose of the auto refill option is to provide user withthe ability to input minimum syringe barrel volumes at which the systemwill automatically replenish the syringes with fluid from the sources.The auto refill option may provide user with ability to set maximumfluid volumes. The auto refill option may also provide user with abilityto set minimum volumes for each syringe. For example, if the userselects the auto refill option so each syringe has a minimum volume of25 mL and after 5 injections the contrast syringe volume falls to 15 mLthe system will detect that the total volume in contrast syringe hasdropped below 25 mL and automatically refill the contrast syringe toeither the total possible volume syringe is capable of holding, such as100 mL, or with 10 mL of fluid. The interface 7 may notify user that theauto refill is taking place but because the user has preprogrammed theauto refill option the contrast syringe will be filled automatically. Anadvantage to the auto refill feature is to save the user time betweeninjections and provide the user with the ability quickly do additionalinjections that may not have been planned at end of the procedure ifneeded. Also, if user is performing multiple large volume injections theauto refill option pervades user with ability to continue performingsuch injections without stopping the case to manually fill syringes.Another advantage of the auto refill option is to provide the ability tocontinue performing injections once the desired volume in syringe hasbeen met.

To set the auto refill option the interface may first check auto refill625 has been selected by user. If user does intend to use auto refilloption, the interface may prompt system to determine if syringe isfilled enough to perform the intended operation 627. If so, theprocedure may continue 629 and there is no need for refill. If not, theinterface may prompt system to confirm auto refill has been enabled 631.If auto fill has not been enabled the interface may notify user 633. Ifauto fill has been enabled the system may determine which syringe is notfull 635. If contrast is not full 637 the system may be prompted to fillcontrast syringe from contrast source 643 until proper volume has beenreached. If saline is not full 639 the system may be prompted to fillsaline syringe from saline source 641. The interface may then promptuser to determine if user wants to abort auto fill 645, if so the systemwill stop filing syringe 647, if not system will continue to fillsyringes from source until complete 649.

After the injector system has been set up, primed, case selected, andthe user is ready to begin the procedure, the user interface willtransition to a dashboard screen 651 as shown in FIG. 48. The parameterson the dashboard screen 651 may be preset depending on the type ofprocedure user selects 609 during injection setup (as seen in flowchartof FIG. 46). The dashboard screen 651 provides user with the option tochange all of the injection parameters previously described above andadditional parameters including, but not limited to, fixed 657 orvariable 659 injection speeds, the type of procedure 655, the contrastratio 661, the flow rate 663, the volume 665, the pressure 667, the risetime 669, source options 683, shell options 685, patient options 687,summary 515, help 689, puff injection 693, end case 691, or arm 671 thesystem for injection. The dashboard screen 652 may also provide aparameter summary box 675 that provides user with clarification on thecurrently set injection parameters.

Advantages of the dashboard screen 651 include providing the user withthe ability to easily and quickly modify various preset parameters ofthe injection that were populated based on type of case selected,determine if the system is armed or disarmed, and visually see what thecurrent volume status is of each syringe and/or source. The dashboardscreen 651 may include the type of case, for example if user selected acardiac case and specifically a coronary procedure then the case type653 may be depicted as a coronary procedure. Also included may be aspecific case type tab 655 indicating the type of case about to beperformed, for example if user is going to perform a left coronaryartery injection. User may have the option to perform either fixed 657or variable 659 speed injections. The dashboard screen 651 may provideuser with visualization and accessibility to control various injectionparameters, including but not limited to, contrast ratio 661, flow rate663, volume 665, pressure 667, and rise time 669. Each injectionparameter may include arrows or other markers indicating the user'sability to easily change the preset or previously set parameter. Forexample, if the preset parameter for a coronary procedure of contrastratio is 50% contrast and 50% saline, but a patient is susceptible tocomplications arising from excess contrast, such as contrast includednephropathy (CIN) as described above, the user may decide to change thecontrast ratio 661 to 20% contrast and 80% saline thereby decreasingamount of contrast needed during the injection but enough contrast tostill provide a clear medical image. To accomplish this change the usermay press the arrows or markers contained within the contrast ratio 661tab and interface may prompt user with a pop-up window that will allowuser to change the contrast to saline ration from 50/50 to the desiredratio. The injection system is capable of injecting 100% contrast and 0%saline, 100% saline and 0% contrast, or any other conceivable ratio ofcontrast and saline therebetween. The dashboard screen 651 may include atab detailing the sources 667 and options 683 to change the sourceranges, shell 679 and options 685 to change the shell ranges, andpatient 681 and options to change the patient ranges, as described inmore detail below and seen in FIG. 50-52. Dashboard screen 651 may alsoinclude a help tab 689, an end case tab 691, a puff tab 693, and aninject tab 695. The system provides for a hand controller, as previouslydescribed above, to control puff and fluid injections, however the usermay also use the puff tab 693 or inject tab 695 in place of the handcontroller. The dashboard may also include an arm tab 671 that the usermay press once the injection parameters have been properly set and thesystem is now ready to start the procedure.

Referring now to FIG. 49, upon arming the system the interface maychange to an armed dashboard screen 699. The armed dashboard screen 699may have many of the same features and tabs as the previously describedunarmed dashboard screen 651; however the armed screen 699 may include anotification bar 697 upon the top portion of the screen. Thenotification bar 697 and inject button 695 may be highlighted, blinking,flashing, include flashing text or visual indications, or otherwiseindicate the system has been armed and is ready for injection. The armeddashboard screen 669 may also include a disarm tab 701 when selectedwould cause interface to switch back to the unarmed dashboard screen 651of FIG. 48.

Referring now to FIG. 50-FIG. 52, the interface allows user to changevarious aspects of the shell option screen 685, source option screen683, and patient option screen 687. The shell option screen 685 mayinclude an information tab 703 indicating how long ago the current shellof the multiple-use subassembly was installed or the number of cases theshell has performed. For example, if each shell is intended to be usedfor either up to 100 hours or a total of 5 patient cases, theinformation tab 703 may be changed or customized to indicate theappropriate indicator. The shell of the multi-use subassembly mayinclude a limit on number of uses, for example up to five patients, orlimit on total usage time, for example up to 12 hours. The limit onshell usage may be preset from the manufacturer or changed by the user.Other shell options include changing the saline vent 705, purge 707, orfill 709 parameters, and changing the contrast vent 711, purge 713, orfill 715 parameters. The saline vent 705, contrast vent 711, includeretracting the plunger in the saline or contrast syringe to variouspositions in order to vent each syringe of air, as described in moredetail above and seen in FIG. 19. The purge 707, 713 options may flushsystem with fluid to remove any trapped air in-line and fill lines withdesired fluid. The fill 709, 715 options includes filling either thecontrast syringe or saline syringe with fluid from the fluid source.Shell option screen 685 may also allow user to change the status of theauto refill option 719, which was previously discussed, or indicate tothe system that the shell is to be removed 721. Source option screen 683provide user with ability to edit parameters 723 of saline source oredit parameters 725 of the contrast source, such as the volume of newcontrast or saline source, or indicate sources need to be replaced 727.Patient option screen 687 allows user to change parameters for amount ofmaximum saline volume 729 or maximum contrast volume 731 the system caninject into the patient.

Referring now to FIG. 53, one embodiment of the summary screen 515 isshown. The summary screen 515 may include a current injection summary733, past injections summary 735, fluid summary 737 and an injectionhistory 738. The current injection summary 733 may include time/date andnumber of injections for the current case, the past injection summary735 may include time/date and number of injections for previous cases.The fluid summary 737 may include details about the saline and contrastfor either the current injection summary 733 or past injection summary735; such details may include as total amount of fluid used, totalamount of fluid delivered to patient, total amount of fluid wasted(i.e., not delivered to patient but still used), and total usage time.The injection history 738 may include a table or chart depicting theinjection parameters compared with what the injection system actuallyperformed, the table may be sortable and include, but is not limited to,the number of injection performed, ratio of contrast, flow, volume, dateof injection, time of injection, name of procedure type, patientcharacteristics, and pressure and rise time for each injection. Theinjection history 739 may also be exported 739 to any computer readableformat or mobile application. The summary screen 515 may be access fromthe setup screen 509, the dashboard screen 651, or the armed dashboardscreen 699.

Referring now to FIG. 54, after the case is complete the user may selectto end case 691 from either dashboard 651 or armed dashboard 699 screen.After case has been ended the interface 7 will then the user through thesequence of post procedure steps, in which in which the interface 7 mayguide the user to first disconnect the tubing set from the patient 741.Next, open quick connect cover and disconnect patient tubing set fromshell 743, dispose patient tubing set in proper manner 745, place asterile end-cap on the shell fitting 747, press end case button 691 (asseen in FIG. 48-49) 749, and switch to connect patient tubing screen 751to prepare for next case. Alternatively, if injection system is intendedfor single patient use only the sequence to end case 691 may includeremoval of the patient tubing and multi-use subassembly. Additionally,the interface 7 may notify user that after a certain number of patientuses, injections or total usage time the multi-use subassembly needs tobe replaced.

Referring now to FIG. 55, the setting screen 517 is shown having acategory tab 752 and a detailed information tab 761. The purpose of thesetting screen 517 is to provide user with access to the currentinjector setting information and the ability to modify the settings.Possible system settings that may be modified through setting screen 517may include auto fill status, minimum auto fill volumes, volume level,and system interface settings such as screen brightness, voice command,and default language. The setting screen 517 may have a category tab 752which may include a general information selection tab 753 (which whenselected prompts the generation information tab 761 as shown); a ratesand volume tab 755, a physical content tab 757, and a procedure presettab 759. Additionally, setting screen 517 options may be passwordprotected to prevent unintended changes to presets. For example, systemmay prevent selected users from changing settings including, but notlimited to, fill rate, priming volumes, procedure types, presetinjection parameters for individual physicians, or any other presetinjection parameter.

Referring now to FIG. 56, the help screen 518 is shown having a topicstab 763 and a detailed information tab 765. The topics tab 763 mayinclude various topics or aspects of the injector that user may needhelp with. The detailed information tab 765 may contain a user manual,or other helpful hints, tips and help information to walk user throughgeneral issues or troubleshooting topics. Detailed information mayinclude videos, audio step-by-step instructions, or live user support.

The phrase “and/or,” as used herein should be understood to mean “eitheror both” of the elements so conjoined, i.e., elements that areconjunctively present in some cases and disjunctively present in othercases. Other elements may optionally be present other than the elementsspecifically identified by the “and/or” clause, whether related orunrelated to those elements specifically identified unless clearlyindicated to the contrary. Thus, as a non-limiting example, a referenceto “A and/or B,” when used in conjunction with open-ended language suchas “comprising” can refer, in one embodiment, to A without B (optionallyincluding elements other than B); in another embodiment, to B without A(optionally including elements other than A); in yet another embodiment,to both A and B (optionally including other elements); etc.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the structure andmethodology of the present invention. Thus, it is intended that thepresent invention cover such modifications and variations provided thatthey come within the scope of the appended claims and their equivalents.

The invention claimed is:
 1. A method to provide injection systemparameters for injecting a fluid into a patient, comprising: placing amulti-use subassembly into an injector housing, the multi-usesubassembly comprising a first fluid barrel and a second fluid barrel, afirst valve and a second valve, the injector housing comprising a firstvalve actuator and a second valve actuator; selecting on a first screenof a user interface a contrast-to-saline ratio of the fluid to beinjected by adjusting a percentage of the contrast contained within thefluid and adjusting a percentage of the saline contained within thefluid so that the fluid to be injected is a mixture of both contrast andsaline, the first valve actuator moves the first valve to a first valvefill position to fill the first fluid barrel with saline and the secondvalve actuator moves the second valve to a second valve fill position tofill the second fluid barrel with contrast in order to obtain theselected contrast-to-saline ratio of the fluid to be injected;displaying a second screen of the user interface which is different fromthe first screen, the second screen having an option to inject the fluidinto the patient, selection of the inject option resulting in the firstvalve actuator to move the first valve to a first inject position andthe second valve actuator to move the second valve to a second injectposition in order to inject the fluid.
 2. The method of claim 1, furthercomprising notifying a user with a visual notification after receivingthe user selection.
 3. The method of claim 2, wherein the visualindication comprises either a disposable sub-assembly has been properlyinstalled, the injection system has been armed, the injection system isperforming an injection, or the injection system has been disarmed. 4.The method of claim 1, wherein the user interface further comprises adisplay unit that is attached to the injection system or a bed rail. 5.The method of claim 4, wherein the display unit is attached to the bedrail or injector system by a movable arm.
 6. The method of claim 5,further comprising the steps of: pulling the moveable arm closer to theuser; and folding the movable arm.
 7. The method of claim 1, furthercomprising displaying on the first screen of the user interface aplurality of selectable options for controlling the injection system. 8.The method of claim 7, wherein the user selection for one of theselectable options further comprises a volume option, pressure option,and a rise time option.
 9. The method of claim 7, wherein the userselection for one of the selectable options further comprises a cardiacprocedure option, a peripheral procedure option, or a physician listoption.
 10. The method of claim 9, wherein changing a system parameteror setting includes a preset injection parameter being populated. 11.The method of claim 7, wherein the plurality of selectable options forcontrolling the injection system comprises the contrast-to-saline ratioand at least one of the following: flow rate, volume, pressure, or risetime.